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Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents.

ABSTRACT: Objective. To assess a comprehensive, intensive lifestyle intervention in combination with metformin extended release (MXR) or placebo on body mass index (BMI) and risk factors for type 2 diabetes and cardiovascular disease in obese adolescents. Study Design. Sixty-nineobese adolescents (mean BMI 32.5) received a comprehensive lifestyle intervention with structured dietary, physical activity, and behavioral components for 24 months. Subjects were randomized to 1 of 4 groups: MXR (33) 2,000?mg daily or placebo, with either moderate or vigorous intensity exercise for the first 3 months. Subsequently the exercise intervention was the same for all 4 groups. Results. Anthropometry measurements did not differ with initial exercise intensity at any time. At 3 months % body fat decreased in all 4 groups (P < 0.006). BMI and % body fat decreased in the MXR groups, but not the placebo groups, at 6 (-0.88, -3.16) and 12 months (-0.56, -2.34) (P < 0.05). Insulin resistance, fasting blood glucose, and leptin improved in all groups at 6 and 12 months. A high subject attrition rate (58%) occurred by 24 months. Conclusion. A comprehensive, intensive lifestyle intervention combined with MXR led to a decline in BMI and % body fat at 1 year independent of initial exercise intensity. This trial is registered with ClinicalTrials.gov NCT00934570 .

SUBMITTER: Clarson CL

PROVIDER: S-EPMC4897295 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents.

Clarson Cheril L CL Brown Hilary K HK De Jesus Stefanie S Jackman Michelle M Mahmud Farid H FH Prapavessis Harry H Robinson Tracy T Shoemaker J Kevin JK Watson Margaret M Dowd A Justine AJ Hill David J DJ

International scholarly research notices 20141110

Objective. To assess a comprehensive, intensive lifestyle intervention in combination with metformin extended release (MXR) or placebo on body mass index (BMI) and risk factors for type 2 diabetes and cardiovascular disease in obese adolescents. Study Design. Sixty-nineobese adolescents (mean BMI 32.5) received a comprehensive lifestyle intervention with structured dietary, physical activity, and behavioral components for 24 months. Subjects were randomized to 1 of 4 groups: MXR (33) 2,000 mg da ...[more]

PMID: 27433488

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Project description:Childhood obesity is a serious health concern affecting over 155 million children in developed countries worldwide. Childhood obesity is associated with significantly increased risk for development of type 2 diabetes, cardiovascular disease and psychosocial functioning problems (i.e., depression and decreased quality of life). The two major strategies for management of obesity and associated metabolic abnormalities are lifestyle modification and pharmacologic therapy. This paper will provide the background rationale and methods of the REACH childhood obesity treatment program.The REACH study is a 2-year multidisciplinary, family-based, childhood obesity treatment program. Seventy-two obese adolescents (aged 10-16 years) and their parents are being recruited to participate in this randomized placebo controlled trial. Participants are randomized to receive either metformin or placebo, and are then randomized to a moderate or a vigorous intensity supervised exercise program for the first 12-weeks. After the 12-week exercise program, participants engage in weekly exercise sessions with an exercise facilitator at a local community center. Participants engage in treatment sessions with a dietitian and social worker monthly for the first year, and then every three months for the second year. The primary outcome measure is change in body mass index and the secondary outcome measures are changes in body composition, risk factors for type 2 diabetes and cardiovascular disease, changes in diet, physical activity, and psychosocial well-being (e.g., quality of life). It is hypothesized that participants who take metformin and engage in vigorous intensity exercise will show the greatest improvements in body mass index. In addition, it is hypothesized that participants who adhere to the REACH program will show improvements in body composition, physical activity, diet, psychosocial functioning and risk factor profiles for type 2 diabetes and cardiovascular disease. These improvements are expected to be maintained over the 2-year program.The findings from this study will advance the knowledge regarding the long-term efficacy and sustainability of interventions for childhood obesity.ClinicalTrials.gov number NCT00934570.

Project description:BackgroundLifestyle intervention may have a critical effect on the association between genetics and obesity. This study aimed to investigate changes in FTO and IRX3 gene expression in obese and overweight male adolescents undergoing a lifestyle intervention and the role of FTO genotype in this interaction.MethodsThis study was a field trial of 62 adolescents from boys' high schools in Tehran, Iran. Two schools were randomly allocated as the intervention (n = 30) and control (n = 32) schools. The rs9930506 SNP in FTO was genotyped at baseline and the level of FTO and IRX3 expression in peripheral blood mononuclear cells (PBMCs). Anthropometric measurements were assessed at baseline and after 18 weeks of intensive lifestyle intervention.ResultsOur results showed that IRX3 expression in the intervention group was significantly up-regulated compared to baseline (P = 0.007) and compared to the control group (P = 0.011).The intervention group had significantly up-regulated transcripts of IRX3 only in rs9930506 risk allele carriers of the intervention group compared to risk allele carriers of the control group (P = 0.017). Moreover, our data showed that the FTO expression was up-regulated in AA genotype carriers and down-regulated in AG/GG genotype carriers (P = 0.017).ConclusionLifestyle modification may exert its effects on obesity through changes in the expression level of the FTO and IRX3 genes. However, FTO genotype plays a role in the extent of the effect of lifestyle changes on gene expression. Further studies are crucial to have a better understanding of the interaction between lifestyle, genetics and anthropometric measurements. Trial registration This paper reports a comprehensive intervention study (Interactions of Genetics, Lifestyle and Anthropometrics study or IGLA study), which is retrospectively registered in the Iranian Registry of Clinical Trials as IRCT2016020925699N2. Date registered: April 24, 2016. ( https://www.irct.ir/searchresult.php?id=25699&number=2 ).

Project description:BackgroundThere is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents. Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents. Our objectives were: 1) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents, in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM (IGI), over and above those of a didactic lifestyle education, on insulin resistance, eating and physical activity behaviors, stress and stress biomarkers; and 2) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes, particularly insulin resistance.MethodsObese (BMI > 95th percentile), Latino adolescents (n = 35, age 14-17) were randomized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program (GI), or lifestyle education plus a digital storytelling computer program (DS). Between-group differences in behavioral, biological, and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention.ResultsThe GI group demonstrated significant reductions in leisure sedentary behavior (p < .05) and increases in moderate physical activity (p < .05) compared to DS group, and a trend toward reduced caloric intake in GI vs DS (p = .09). Salivary cortisol was acutely reduced by stress-reduction guided imagery (p < .01). There were no group differences in adiposity, insulin resistance, perceived stress, or stress biomarkers across the 12-week intervention, though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity (p = .03) independent of intervention group and other relevant co-variates.ConclusionsThe improvements in physical activity and stress biomarkers following this pilot intervention support the role of guided imagery in promoting healthy lifestyle behavior change and reducing metabolic disease risk in obese Latino adolescent populations. Future investigations will be needed to determine the full effects of the Imagine HEALTH intervention on insulin resistance, stress, and stress biomarkers.Trial registrationClinicaltrials.gov Registry #: NCT01895595.

Project description:BackgroundStudies of lifestyle intervention programs in morbid obesity report large variations in weight loss outcomes. This is reported not only between but also within standardized programs. Such reports point to participants' characteristics as possible predictors of this outcome. The aim of this prospective cohort study was to identify predictors of weight loss after a 1-year partly residential intensive lifestyle intervention program (ILI).MethodsMorbidly obese patients (n=199), all Caucasian, 71% women, mean (SD) age 45.2 (11.1) years, body mass index (BMI) 42.0 (6.2) kg/m(2), and excess body weight (>BMI=25 kg/m(2)) 49.4 (19.6) kg, were referred from public hospitals to a rehabilitation center and enrolled consecutively. The 1-year ILI comprised of four (n=104) or five (n=95) stays at the rehabilitation center. In both cases there was one main stay for 4 weeks and the remaining stays lasted 1 week each. In the home periods the patients were followed up by telephone and by their general practitioners (GP). The patients were also encouraged to use a predefined paper based diary. Health related quality of life (HRQL), diagnostic, anthropometric, socio-demographic, psychosocial and intervention characteristics were measured at baseline, 12 weeks and 1 year. Multiple linear regression analyses were performed to extract possible predictors of weight loss at 1-year. Direct and indirect effects of these predictors were tested through structural equation modeling.ResultsThe mean (SD) 1-year weight loss was 10 (11) kg, corresponding to an 8 (8) % reduction of body weight from baseline. Mean excess weight loss (EWL) was 20 (22) % ranging from 104% to -77%. The adherence to a diary (r=.16), type 2 diabetes (r=-.14) and frequency of GP-visits (r=.23) were significantly associated with EWL at 12 weeks. Predictors of 1-year EWL were 12 week EWL (r=.66), occupational status (r=.11), age (r=.19), and mental HRQL (r=-.16), all p<.05. The path model explained 50% of the variation (r(2)=.50) of 1-year EWL.ConclusionLarger 12 week weight loss, being employed, lower mental HRQL and being older predicts larger weight loss after 1 year in morbidly obese patients following ILI. Not having type 2 diabetes, using a diary combined with regular GP follow-up influence the 12-week weight loss.Trial registrationClinicaltrials.gov: NCT00477399.

Dataset Information

Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents.

Publications

Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents.

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